Vesica Health develops the AssureMDx test, a noninvasive urine-based diagnostic tool that analyzes specific DNA biomarkers to assess the risk of bladder cancer in patients presenting with hematuria. This technology enables physicians to accurately identify high-risk individuals for timely urology referrals while allowing low-risk patients to avoid unnecessary invasive procedures.
Funding
Funding not disclosed
Founders
Product
Problem
The current diagnostic pathway for bladder cancer often relies on invasive procedures like cystoscopy, which can be uncomfortable and costly for patients presenting with hematuria. Many patients with hematuria do not have bladder cancer, leading to unnecessary procedures and increased healthcare costs.
Solution
Vesica Health's AssureMDx test is a non-invasive, urine-based diagnostic tool designed to improve the detection and management of bladder cancer. The test analyzes specific DNA biomarkers in urine to assess a patient's risk of harboring bladder cancer. By identifying patients at high risk, AssureMDx enables timely referrals to urology for clinical evaluation. Conversely, it allows physicians to identify patients at very low risk who may safely avoid unnecessary invasive procedures, reducing patient burden and healthcare expenses. The test leverages a proprietary multi-omic approach, combining epigenetic and somatic mutation analysis to provide actionable results.
Target Audience
The primary target audience includes primary care physicians and urologists who evaluate patients presenting with hematuria, as well as patients who require monitoring for bladder cancer recurrence.
Features
- Non-invasive urine test for bladder cancer risk assessment
- Analyzes DNA methylation status of OTX1, ONECUT2 and TWIST1 genes
- Detects somatic mutations in FGFR3, TERT and HRAS genes
- Provides a binary risk assessment: high-risk or very low-risk
- High sensitivity (96%) and negative predictive value (99.6%)
- Reduces the need for unnecessary cystoscopies and CT scans
- Improves early detection of bladder cancer, especially in women